NCT03818906

Efficacy of aPDT in Reducing Pain and Swelling Following Molar Extraction Surgery- Blinded Randomized Controlled Clinical Trial

Completed NA Last updated 30 November 2022

What this trial tests

NA trial testing Molar extraction - Control Group in Tooth Extraction Status Nos in 40 participants. Completed in 1 January 2019.

Timeline

1 August 2018

Primary endpoint
1 January 2019

1 January 2019

Quick facts

Lead sponsor	Universidade Federal Fluminense
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	40
Start date	1 August 2018
Primary completion	1 January 2019
Estimated completion	1 January 2019
Sites	1 location across Brazil

Drugs / interventions tested

• Molar extraction - Control Group
• aPDT + Molar Extraction - Test Group 1
• Infrared + Molar Extraction - Test Group 2
• aPDT + Infrared + Molar Extraction - Test Group 3

Conditions studied

• Tooth Extraction Status Nos — all drugs for Tooth Extraction Status Nos →

Sponsor

Universidade Federal Fluminense — full company profile →

Who can join

Adults 20 to 60, any sex, with Tooth Extraction Status Nos. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This project aims to evaluate the effect of antimicrobial photodynamic therapy (aPDT) on the reduction of swelling and postoperative pain in lower molar extraction procedures. This is a clinical study approved by the Research Ethics Committee, which will be performed in 40 patients between 20 and 60 years. Patients included in the study should have at least one lower molar (first or second molar) with indication of exodontia. Participants will follow the exclusion criteria: pregnant or breastfeeding women; patients with obesity (Body Mass Index - BMI); make use of any activity smokers and ex smoker to 6 months; diabetics; immunosuppressed; in osteoporosis; making use of antimicrobials in the last 3 months; making use of medications that interfere with bone remodeling; with cysts or tumors in place. Surgical procedures that exceeded the clinical time of 30 minutes and / or required opening of the flap or osteotomy were excluded from the study. After the sample calculation, forty patients will be involved in this project, where forty molars (first and second molars) will be extracted in the mandible, which will be randomly divided into 4 groups. The control group (C.G), will contain 10 patients, where 10 molars will be extracted in a conventional way, without any additional treatment to be done. Test group 1 (T.G1) will contain 10 patients where 10 molars will be extracted and immediately after extraction, the fresh sockets will receive in their inner portion a local application of aPDT. The test group 2 (T.G2) will present 10 patients, where 10 molars will be extracted that immediately after the exodontia, the fresh socket will receive local application of infrared in the outer vestibular portion. Finally, Test Group 3 (T.G3), will be composed of 10 patients, where 10 molars will be extracted, joining the approaches of the previous groups (aPDT + infrared). Pain intensity will be assessed through a visual analogue scale and swelling assessed by measuring a perimeter between the tragus, the base of the jaw and the commissure of the lips. The data will be collected in four moments: before the surgery, 72 hours, 7 days and 30 days postoperatively.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.